CytoSorbents (CTSO) Projects $37M Revenue for 2025, FDA Meeting Scheduled
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
0mins
Source: PRnewswire
- Financial Outlook: CytoSorbents anticipates fourth quarter and full-year 2025 revenues of approximately $9.2 million and $37 million, respectively, with expected gross margins between 73% and 75%, indicating stable growth potential in the market.
- FDA Meeting Scheduled: The company plans to hold a Pre-Submission Meeting with the FDA this month regarding DrugSorb®-ATR, with a De Novo application expected to be filed this quarter and a regulatory decision anticipated in mid-2026, paving the way for market entry.
- Research Publication: Results from the pivotal STAR-T study for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, reflecting the clinical relevance of the technology and potentially enhancing the company's reputation and market recognition in the medical community.
- Operational Improvements: The company is implementing various process improvements and a global strategic workforce and cost reduction program, expecting to accelerate its path to profitability and achieve approximately operating cash flow break-even in Q1 2026, thereby strengthening its financial health.
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Analyst Views on CTSO
Wall Street analysts forecast CTSO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CTSO is 0.75 USD with a low forecast of 0.75 USD and a high forecast of 0.75 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
0 Buy
1 Hold
0 Sell
Hold
Current: 0.659
Low
0.75
Averages
0.75
High
0.75
Current: 0.659
Low
0.75
Averages
0.75
High
0.75
About CTSO
CytoSorbents Corporation is engaged in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. The Company’s blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its lead product, CytoSorb, is an extracorporeal blood purification cartridge to reduce cytokine storms in common critical illnesses that can lead to massive inflammation, organ failure and patient death. Its products also include ECOS-300CY, VetResQ, DrugSorb-ATR, and PuriFi. DrugSorb-ATR is an investigational device that uses equivalent polymer technology to CytoSorb to address a large unmet need for blood thinner reversal in cardiothoracic surgery. ECOS-300CY is used to reduce cytokines and other inflammatory mediators when used in an ex vivo organ perfusion system.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
CytoSorbents (CTSO) Projects $37M Revenue for 2025, FDA Meeting Scheduled
- Financial Outlook: CytoSorbents anticipates fourth quarter and full-year 2025 revenues of approximately $9.2 million and $37 million, respectively, with expected gross margins between 73% and 75%, indicating stable growth potential in the market.
- FDA Meeting Scheduled: The company plans to hold a Pre-Submission Meeting with the FDA this month regarding DrugSorb®-ATR, with a De Novo application expected to be filed this quarter and a regulatory decision anticipated in mid-2026, paving the way for market entry.
- Research Publication: Results from the pivotal STAR-T study for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, reflecting the clinical relevance of the technology and potentially enhancing the company's reputation and market recognition in the medical community.
- Operational Improvements: The company is implementing various process improvements and a global strategic workforce and cost reduction program, expecting to accelerate its path to profitability and achieve approximately operating cash flow break-even in Q1 2026, thereby strengthening its financial health.
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CytoSorbents Reports $37M in Q3 Sales; CEO to Join Virtual Discussion
- Strong Sales Performance: CytoSorbents achieved $37 million in high-margin sales over the trailing 12 months, reflecting robust market demand in critical care and cardiac surgery, thereby establishing a solid foundation for future growth.
- Accelerated Regulatory Progress: The company is actively pursuing FDA approval for DrugSorb™-ATR, with a key regulatory decision expected in mid-2026, which will provide crucial support for expanding its product line and market penetration.
- Executive Participation in Discussion: CEO Phillip Chan and CFO Peter J. Mariani will join a virtual discussion hosted by D. Boral Capital on December 15, offering insights into the company's recent financial performance and future strategies, aimed at bolstering investor confidence.
- Innovative Technology Outlook: CytoSorbents' blood purification technology is utilized in over 70 countries with nearly 300,000 devices used cumulatively, showcasing its broad application potential in treating life-threatening conditions and further solidifying the company's leadership in the medical technology sector.
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